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Trial Title:
Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection
NCT ID:
NCT05767528
Condition:
Muscle-Invasive Bladder Carcinoma
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Muscle-Invasive Bladder Carcinoma (MIBC)
Patient-derived tumor-like cell clusters (PTC)
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing
Description:
Conducting the neoadjuvant therapy of FDA-approved drugs for patients with
muscle-invasive bladder carcinoma, culturing the patient-derived tumor-like cell clusters
for drug sensitivity testing simultaneously, then assess the accuracy of the diagnostic
test by combination and analysis of these results
Arm group label:
Case Group
Summary:
In this study, investigators plan to conduct the 3D in vitro culture PTC drug sensitivity
testing of fresh tumor specimen which obtained by endoscopic biopsy or other methods.
Through assessing the consistency between the testing results and the patients'
neoadjuvant treatment outcomes, they would evaluate the accuracy of PTC drug sensitivity
testing and its application value in the individualized precision medicine for
muscle-invasive bladder carcinoma.
Detailed description:
This is a prospective observational study. In this study, researchers propose to enroll
40 participants above 18 years of age with muscle-invasive bladder carcinoma, who are
going to receive the neoadjuvant therapy before surgery. Collecting fresh tumor samples
for PTC drug sensitivity testing, conducting neoadjuvant therapy for the subjects
simultaneously. By combining PTC prediction results with the patients' clinical treatment
process and medication feedback, researchers could estimate the accuracy of PTC drug
sensitivity testing. Completion of this research would provide real-world figures to
support for the clinical application for PTC drug sensitivity testing, and a method is
going to be established to guide the clinical treatment regimen for patients with
muscle-invasive bladder carcinoma.
Criteria for eligibility:
Study pop:
Urology patients with muscle-invasive bladder carcinoma above 18 years of age, at Chinese
PLA General Hospital
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 1 The lesion of biopsy was diagnosed as muscle-invasive bladder cancer
- 2 Age ≥ 18 years old, regardless of gender
- 3 Treatment plan of bladder removal surgery
- 4 Neoadjuvant therapy before surgery
- 5 Adequate fresh tumor tissue can be obtained by endoscopic biopsy for PTC drug
sensitivity testing
- 6 ECOG 0-1, expected survival is more than 3 months
- 7 Normal or stable hepatic, renal, and hematopoietic function
- 8 Normal or stable blood pressure
- 9 The subjects are willing to participate, sign an informed consent form, and have
good compliance
Exclusion Criteria:
- 1 Patients with incomplete clinical data
- 2 Central nervous system metastasis
- 3 The presence of other malignant diseases was discovered during treatment, which is
going to interfere the study
- 4 Researchers believe that the patient is not suitable for participation after
comprehensive evaluation
- 5 Refuse the treatment or follow-up plans
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Shaoxi Niu, M.D.&Ph.D.
Phone:
+8613911353443
Email:
g4niuniu@163.com
Start date:
December 8, 2022
Completion date:
December 8, 2024
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing GeneX Health Technology Co., Ltd
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05767528
